mirtazapine in cancer-related poly-symptomatology

Conditions: Cancer; Neoplasms; Neoplasm Metastasis

Summary: multicenter, prospective, randomized, controlled trial based on a mixed-method methodology using parallel groups, of oral mirtazapine (intervention) compared with oral escitalopram (control), with a 56 days follow-up. improvement of the global health status (issued from the eortc-qlq-c30 (quality of life questionnaire)) will be used as the primary outcome on day 56. semi-structures interviews will be performed on a purposive sample for qualitative analysis. the 418 participants will be followed-up at day 7, 14, 28 and 56 for a 56 days period. a sub-group of participants will be invited to take part into qualitative interviews at baseline and day 56. recruitment of participants to the qualitative part will be based on a purposive sampling.


Eligibility criteria:
inclusion criteria: * being over 18 years old * suffering from advanced cancer * having a clinically estimated life expectancy over 3 months. * being diagnosed from having a depressive syndrome by a hospital anxiety and depression scale-d over 11. * being in need of an antidepressant treatment. * suffering from at least one under-controlled symptom (defined as a score over 3 on the edmonton symptom assessment scale) among: pain, nausea, vomiting, breathlessness, lack of appetite, sleep disorders, anxiety or impaired wellbeing. * having or not a cancer treatment. * being able to understand the information related to the study, and to sign informed consent. * having agreed to take part to the study. * being able to fill patient reported outcomes questionnaires. * being available to be call on days 7 and 14. * having a social security affiliation. exclusion criteria: * being treated by an antidepressive agent during the four weeks before inclusion. * having had a hypersensitivity event to mirtazapine, escitalopram of any excipient. * having had a prior inefficient treatment by mirtazapine or escitalopram. * having postural hypotension or arterial systolic hypotension inferior to 90 mmhg measured following the guidelines of the european society of cardiology * having a qt interval over 420 ms. * having uncontrolled hearth rhythm disorder or uncontrolled conduction disorder. * having had or having bipolar disorder. * having uncontrolled seizure or epilepsy (relative non-inclusion criteria needing a neurology specialist opinion) * having or having history of closed-angle glaucoma. * having bone marrow aplasia. * practicing breast-feeding or being pregnant. * women of childbearing age with no contraception method. * having a treatment with: * monoamine oxidase inhibitors (selegiline, moclobemide, isocarboxazid, nialamide, phenelzine, tranylcypromine, iproniazid, iproclozide, toloxatone, linezolid, safinamide, rasagiline) * one of the following antiarrhythmic drugs: flecainide, propafenone, any class ia and iii antiarrhythmic drug (amiodarone, disopyramide, hydroquinidine, quinidine, procainamide, sparteine, ajmaline, prajmaline, lorajmine, bretylium tosilate, bunaftine, dofetilide, ibutilide, tedisamil, dronedarone). * linezolid, sparfloxacin, moxifloxacin, macrolides (iv erythromycin, josamycin, clarithromycin, telithromycin), pentamidin, halofantrine, hiv protease inhibitors (ritonavir, nelfinavir, amprenavir, indinavir), azolic antifungal agents (ketoconazole, itraconazole, miconazole, fluconazole, voriconazole) * mizolastine and astémizole * st. john's wort * having genetic galactose intolerance or glucose-galactose malabsorption. * having one of the following electrolyte disorders not corrected at the time of inclusion: hyponatremia, hyperkalemia, hypokalemia, hypermagnesemia, and hypomagnesemia. * having end-stage renal disease with a creatinine clearance inferior to 15 ml/min calculated using the cockroft's formula. * having hepatic failure. * having legal incapacity

Keywords: cancer symptom management poly-symptomatology mirtazapine antidepressive drugs